Warning letter
Onkos Surgical, Inc.: warning letter of Jul 21, 2025
FDA warning letter 712573 · Center for Devices and Radiological Health
Key facts
| Reference number | 712573 |
|---|---|
| Company | Onkos Surgical, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jul 21, 2025 |
| Posted date | Jul 29, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 806.10, 806 |
| Inspection city | Parsippany |
| Inspection ZIP | 07054-3714 |
| Inspection start date | Feb 4, 2025 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: